When do FORMs and Log Files become Records?

ISO_Man

Involved In Discussions
#1
I trust that everyone is staying safe and healthy.

I have a question, and if I might ask, please don't ask me what my document control policy says .. I own that policy and I'm looking for advice to change it.

I have someone who uses a file daily, it's created with a form, let's call it XYZ. As soon as she downloads a copy of XYZ and starts using it, it's no longer a released form, but a record based on that form. She uses the form all of the time as a log file of activity, and may end up using it for months, simply adding to the form. As she adds new information other's need to be able to see the form also.

Scenario is this - she uses the file indefinitely, it gets backed up automatically every day/week whatever - but no changes to the original, released version of XYZ. Is there anything in ISO-9001, other than the protection of data,etc. - what prevents her from doing this?

Other considerations?

Thanks for your help.
 
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heiss

Starting to get Involved
#2
Hi,

We have multiple log files that are used similar to what you described. The way we deal with such files, is the template of the form is controlled, and is in the master document list. As long as the user is not changing the functions of the form I don't see an issue with it.
 

ISO_Man

Involved In Discussions
#3
Hi,

We have multiple log files that are used similar to what you described. The way we deal with such files, is the template of the form is controlled, and is in the master document list. As long as the user is not changing the functions of the form I don't see an issue with it.
Are you ISO-9001:2015 certified?
 

Jim Wynne

Staff member
Admin
#4
In most cases, forms do not have to be controlled. Instead, control the information that's to be recorded via a documented procedure "documented information." Specify in the document that any convenient format may be used. You can still provide a form. In your situation, what happens when the form changes while it's in the sort of continual use that you describe?
 

ISO_Man

Involved In Discussions
#5
In most cases, forms do not have to be controlled. Instead, control the information that's to be recorded via a documented procedure "documented information." Specify in the document that any convenient format may be used. You can still provide a form. In your situation, what happens when the form changes while it's in the sort of continual use that you describe?
Nothing other than the addition of information. I've explained to the process owner that they can decide much "permanent" information is in the form and how much "changeable" information so that they can determine how frequently the form would need to be re-released.
 

Jim Wynne

Staff member
Admin
#6
Nothing other than the addition of information. I've explained to the process owner that they can decide much "permanent" information is in the form and how much "changeable" information so that they can determine how frequently the form would need to be re-released.
Is form XYZ controlled in your system?
 

Jean_B

Trusted Information Resource
#8
The case sounds more akin to a log receiving (multiple) record entries, than a form producing a single complete record (set of data linked to that record entry's unique identifier). Thus it is like controlling a database. The essential thing there is if you add a column to the table how to assess it over previous record entries (nil, null, not available, do calculate/retrospectively add) , and that you don't kill off what (column) makes a record entry uniquely identifiable.
Since this is not digital, you'd look at it as if it's at the highest level of control in the olden days: (classified) laboratory logbook.
Have the form's issue (verb) be authorized: and the authorizer notes a unique log identifier on the form (now becoming a record), that unique identifier in their own controlled copy log (which may be specific to this form, nothing prevents you having multiple), as well as date of issue, issued to, field location, revision of issue. You'll have further columns for date retrieved and perhaps some metadata to allow the log to serve easily as an index, which are only filled in as the finished (even if not full) is returned.
Add in an audit on this type of control process: issue, in field retention, returns. Or add a interval based check on each such issued item to see whether it's still there.
If you think they might be lost, prepare a comment field or other type of explanatory control. You don't want to be caught having to investigate what happened because someone else found out it's missing.
It's most akin to issuing controlled copies of already approved documents, but you won't scrap them in the field when superseded as what's added to them is essential.
 
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